• 한방비만학회지
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• 제22권2호
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• pp.136-146
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• 2022

Objectives: The objective of this study is to evaluate weight change and analyze adverse events in overweight and obese women with polycystic ovary syndrome (PCOS) who were prescribed with Gamitaeeumjowee-tang. Methods: A retrospective chart review was conducted for medical records of patients with PCOS, who were administered with Gamitaeeumjowee-tang for a period of 12 weeks between January 2019 and December 2021. Outcomes were total weight loss/weight loss rate, the percentage of patients who lost more than 5% and 10% of their baseline weight. Adverse events (AEs) reported by patients were evaluated by severity, causality and system-organ classes. Results: A total of sixty-seven patients were included (mean±standard deviation, Age 28.78±5.25 years, weight 76.78±12.84 kg, body mass index 29.2±4.26 kg/m²). The average total weight loss in PCOS patients was 6.57±3.07 kg and the average weight loss rate was 8.55±3.65%. The percentage of patients with more than 5% and 10% weight loss compared to their baseline weight was 86.56% and 25.37% respectively. The analysis of adverse events are as follows: Causality assessment with World Health Organization-Uppsala Monitoring Centre of AEs showed 'Unlikely' was the most common (71.7%) and severity evaluations with Common Terminology Criteria for Adverse Events showed almost all symptoms were mild (98.9%). Conclusions: Gamitaeeumjowee-tang helps to lose weight of PCOS patients, which is overweight or obese, and no serious adverse events have occurred. Additional well-designed clinical studies are recommended.

• 대한한의학회지
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• 제43권3호
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• pp.65-78
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• 2022

Objectives: The purpose of this study is to analyze the weight loss and the adverse events of overweight and obese adults on weight loss program with face-to-face treatment (FTF) and non-face-to-face treatment (NFTF) in 6 Korean Medicine obesity clinics. Methods: From March 2nd to March 10th, 2021, we collected data with a retrospective way from overweight and obese adults (body mass index, BMI≥23 kg/m²) who registered for a 12-week Gamitaeeumjowi-tang prescription program. After matching initial information of the FTF group and the NFTF group using propensity matching score, weight loss and BMI change were analyzed, and adverse events were evaluated in terms of causality, severity and system-organ classes. Results: Weight and BMI change from baseline to 12 weeks was -7.98±3.09kg (10.41±3.57%), -3.03±1.14kg/m² and -7.30±3.11kg (9.59±3.45%), -2.76±1.15kg/m² for FTF group and NFTF group, respectively. Body weight and BMI significantly decreased before and after treatment in both groups, and there was no significant difference in weight loss and BMI change between the two groups. No serious adverse events were reported. Conclusions: This study showed the potential that NFTF weight management treatment could be a good alternative way to FTF weight management treatment without serious adverse events.

• Tuberculosis and Respiratory Diseases
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• 제80권2호
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• pp.143-152
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• 2017

Background: Fluoroquinolones are considered important substitutes for the treatment of tuberculosis. This study investigates the current status of fluoroquinolone for the treatment of tuberculosis. Methods: In 2009, a retrospective analysis was performed at one tertiary referral center for 953 patients diagnosed with tuberculosis. Results: A total of 226 patients (23.6%), who received fluoroquinolone at any time during treatment for tuberculosis, were enrolled in this study. The most common reasons for fluoroquinolone use were adverse events due to other anti-tuberculosis drugs (52.7%), drug resistance (23.5%), and underlying diseases (16.8%). Moxifloxacin (54.0%, 122/226) was the most commonly administered fluoroquinolone, followed by levofloxacin (36.3%, 82/226) and ofloxacin (9.7%, 22/226). The frequency of total adverse events from fluoroquinolone-containing anti-tuberculosis medication was 22.6%, whereas fluoroquinolone-related adverse events were estimated to be 2.2% (5/226). The most common fluoroquinolone-related adverse events were gastrointestinal problems (3.5%, 8/226). There were no significant differences in the treatment success rate between the fluoroquinolone and fluoroquinolone-$na{\ddot{i}}ve$ groups (78.3% vs. 78.4%, respectively). Conclusion: At our institution, fluoroquinolones are commonly used for the treatment of both multidrug-resistant tuberculosis and susceptible tuberculosis, especially as a substitute for adverse event-related drugs. Considering the low adverse event rates and the comparable treatment success rates, fluoroquinolones seem to be an invaluable drug for the treatment of tuberculosis.

• International journal of thyroidology
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• 제11권2호
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• pp.75-77
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• 2018

Tyrosine kinase inhibitor is known to prolong progression free survival in radioiodine refractory thyroid cancer patients. Fatigue/asthenia/malaise is one of most common adverse events by the tyrosine kinase inhibitor treatment, and management of the adverse event is important to keep the drug medication longer which is essential for the survival benefit. In the case report, a radioiodine refractory thyroid cancer patient receiving tyrosine kinase inhibitor experienced severe fatigue, and a pathologic fracture of right humerus occurred by slipping down which was tightly linked with the adverse event of the drug. The pathologic fracture was surgically well managed and the adverse event was well controlled by supportive managements combined with dose reduction of the tyrosine kinase inhibitor. The drug administration to the patient was kept more than 1 year without progression of the disease.

• 한국임상약학회지
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• 제24권2호
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• pp.106-114
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• 2014

Purpose: Recent investigations suggest that the antiplatelet effect of clopidogrel may be decreased when this medication is taken together with certain proton pump inhibitors (PPIs). However, there has been no study conducted in Korea regarding the clinical effect of clopidogrel-PPI interaction. This study targeted patients who received stents to investigate the effect of the concomitant use of clopidogrel and PPIs on the occurrence of adverse cardiovascular events in Korean patients. Methods: The patients who received a stent insertion at the Yeouido St. Mary's Hospital between January 2010 and April 2011 were included. The patients were divided into two groups, clopidogrel and clopidogrel + PPI, and followed for 12 months after the date of stent insertion using prescription history and medical records. The recurrence rates of the cardiovascular events among the two patient groups were statistically analyzed. Results: There was no difference between the two groups in the basic characteristics of the 157 patients in the clopidogrel group and the 62 patients in the clopidogrel+PPI group. Simple logistic regression showed a significantly higher rate of re-hospitalization in the clopidogrel+PPI group (OR=1.893, 95% CI 1.040-3.445, p=0.037). However, the results of the multivariate logistic regression of the variables found to have statistical significance by crosstabulation showed no significant difference in the rate of adverse cardiovascular events or re-hospitalization between the two groups. Conclusions: There was no significant difference between the clopidogrel and clopidogrel+PPI group among new patients with cardiovascular stents with respect to the occurrence of revascularization procedures, stent thrombosis, or chest pain, or with respect to the re-hospitalization rate for all cardiovascular events.

• 한국임상약학회지
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• 제31권4호
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• pp.324-331
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• 2021

To investigate signals of adverse drug reactions of finasteride by using the Korea Adverse Events Reporting System (KAERS) database. This pharmacovigilance was based on the database of the drug-related adverse reactions reported spontaneously to the KAERS from 2013 to 2017. This study was conducted by disproportionality analysis. Data mining analysis was performed to detect signals of finasteride. The signal was defined by three criteria as proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). The signals of finasteride were compared with those of the other drugs; dutasteride (similar mechanism of action), minoxidil (different mechanism but similar indications for alopecia), silodosin (different mechanism but similar indications for BPH). It was examined whether the detected signals exist in drug labels in Korea. The total number of adverse event-drug pairs was reported 2,665,429 from 2013 to 2017, of which 1,426 were associated with finasteride. The number of investigated signals of finasteride was 42. The signals that did not include in the drug label were 29 signals, including mouth dry, hypotension, dysuria etc. The signal of finasteride was similar to that of dutasteride and silodosin but was different to that of minoxidil. Early detection of signals through pharmacovigilance is important to patient safety. We investigated 29 signals of finasteride that do not exist in drug labels in Korea. Further pharmacoepidemiological studies should be needed to evaluate the signal causality with finasteride.

• 한국임상약학회지
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• 제32권3호
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• pp.226-237
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• 2022

Background: Monoclonal antibodies for the treatment of patients with different types of cancer, such as cetuximab, have been widely used for the past 10 years in oncology. Although drug information package insert contains some representative adverse events which were observed in the clinical trials for drug approval, the overall adverse event patterns on the real-world cetuximab use were less investigated. Also, there have been no published papers that deal with the full spectrums of adverse drug events of cetuximab using national-wide drug safety surveillance systems. Methods: In this study, we detected new adverse event signals of cetuximab in the Korea Adverse Event Reporting System (KAERS) by utilizing proportional reporting ratios, reporting odds ratios, and information components indices. Results: The KAERS database included 869,819 spontaneous adverse event reports, among which 2,116 reports contained cetuximab. We compared the labels of cetuximab among the United States, European Union, Australia, Japan, and Korea to compare the current labeling information and newly detected signals of our study. Some of the signals including hyperkeratosis, tenesmus, folliculitis, esophagitis, neuralgia, disseminated intravascular coagulopathy, and skin/throat tightness were not labeled in the five countries. Conclusion: We identified new signals that were not known at the time of market approval.

• 한국대기환경학회지
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• 제32권3호
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• pp.237-247
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• 2016

Global climate change is becoming one of the greatest challenges facing humanity. This article proposes a psychological perspective of climate change adaptation. Climate change-related severe adverse weather events may trigger mental health problems, including increased post-traumatic stress disorder (PTSD), depression, anxiety, violence, and even suicide. Forced migration could be considered a coping method for dealing with weather events, but it may also pose a psychological threat. People respond to severe weather events in different ways based on their individual characteristics. Psychological risks from adverse weather events are mediated and moderated by these factors, which are influenced by personal cognition, affect, and motivation. Examinations from a psychological perspective, which have been neglected in the science of climate change thus far, may provide keys to successful adaptation and the prevention of serious psychological problems resulting from the experience of severe weather events. A new prevention strategy has been suggested for coping with climate threats through encouraging attitude change, establishing proactive support systems for vulnerable groups, establishing a PTSD network, and implementing a stress inoculation program.

• 한국임상약학회지
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• 제20권1호
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• pp.56-65
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• 2010

Objective: This study aimed to develop information materials on vaccine's safety and adverse events which can be utilized by healthcare professionals when prescribing, dispensing and administering vaccines and also by non-healthcare professionals such as pharmaceutical distributors of vaccine. Methods: Information materials regarding vaccines from domestic and foreign governmental organizations, academies, medical organizations and pharmaceutical companies were reviewed. Advisory Committee which consisted of experts in the areas of the vaccine's safety verified the contents and the final information material. Results: Based on the collected data, we developed general guidelines including vaccine constituents, safety information and adverse events of each vaccines, storage and handling, and labeling information. The information materials were developed for both healthcare professionals and non-healthcare professionals such as vaccine distributors. Conclusion: Information materials on vaccine's safety and adverse events developed from this study could be utilized to provide useful information on the vaccine to the medical institutions and distributors.

• Journal of Acupuncture Research
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• 제39권1호
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• pp.29-35
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• 2022

Background: Electronic moxibustion has the advantage of temperature control and maintenance, and overcomes the limitations of the existing moxibustion process without the use of the combustion process. However, as the application of electronic moxibustion in clinical practice has increased, safety issues are emerging. Methods: Clinical cases of electronic moxibustion treatment for knee osteoarthritis where burns occurred were collected. In addition, adverse events reported in clinical studies using electronic moxibustion for patients with knee osteoarthritis were collected from studies retrieved from Korean and international databases. Results: There were 3 cases of superficial 2^nd degree burns retrospectively collected through chart reviews. Among the selected 5 studies for literature review, 2 studies reported adverse events which were burns milder than those reported in these 3 cases in this retrospective case review. Conclusion: Since the risk of superficial 2^nd degree burn was discovered in the cases reviewed, further research on safe electronic moxibustion treatment is required without compromising the effectiveness of moxibustion.